Clinical trials: Valvular Aortic Stenosis
Symptomatic Severe Aortic Stenosis
Early Feasibility Study (EFS) of Abbott's Balloon-expandable (BE) TAVI System for the Treatment of Severe, Symptomatic Aortic Stenosis
The purpose of this study is to evaluate the safety and functionality of Abbott's BE TAVI system for the treatment of patients with symptomatic severe aortic valve stenosis.
- Trial name
- NCT07116551
- Testing
- Abbott BE TAVI System
- Where
- 5 sites in United States, France
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Abbott Medical Devices
Hypertrophic Cardiomyopathy
Efficacy, Safety, and Tolerability of Perhexiline in Subjects With Hypertrophic Cardiomyopathy and Heart Failure
A Study on the Efficacy, Safety, and Tolerability of Perhexiline maleate in Subjects with Hypertrophic Cardiomyopathy and Moderate-To-Severe Heart Failure
- Trial name
- NCT02431221
- Testing
- Perhexiline
- Sponsor
- Heart Metabolics Limited
Hypertrophic Cardiomyopathy
A Trial of HRS-1893 in Healthy Volunteers
The purpose of this study is to assess the safety and PK characteristics of a single oral dose of HRS-1893 in healthy voluunters.
- Trial name
- NCT07033455
- Testing
- HRS-1893
- Where
- Australia
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Atridia Pty Ltd.
Symptomatic Aortic Stenosis
Optimize PRO Study
The purpose of this study is to collect clinical evidence on valve performance and procedural outcomes associated with an "optimized" TAVR care pathway and post-TAVR conduction disturbance pathway while using the Evolut™ PRO and…
- Trial name
- NCT04091048
- Testing
- Evolut™ PRO and Evolut™ PRO+ System (Evolut™ FX System for the addendum)
- Where
- 60 sites in United States, Australia and 10 more
- Volunteers
- 1,127 people
- Sponsor
- Medtronic Cardiovascular
Aortic Stenosis Treated With TAVI
Zhicheng TAVR Robot
Use of the Transcatheter Aortic Valve Replacement Surgical Assist System and its Disposable Kit in Patients With Severe Aortic Stenosis to Evaluate the Safety and Efficacy of the Transcatheter Aortic Valve Replacement Surgical…
- Trial name
- NCT07392359
- Testing
- TAVR Assistance System, TAVR by manual
- Volunteers
- 158 people, healthy volunteers welcome
- Sponsor
- Zhicheng Medical Technology (Jiaxing) Co, Ltd
Aortic Stenosis
Feasibility Study of the transShield Embolic Protection System
The objective of this study is to evaluate the initial safety and performance of the transShield EPS used for embolic protection during Transcatheter Aortic Valve Replacement (TAVR).
- Trial name
- NCT06652841
- Testing
- transShield Embolic Protection System
- Where
- New Zealand
- Volunteers
- 2 people
- Sponsor
- TransAortic Medical, Inc.
Cardiomyopathy, Hypertrophic, Cardiomyopathy, Hypertrophic, Familial
Open-Label Study of Perhexiline in Patients With Hypertrophic Cardiomyopathy and Moderate to Severe Heart Failure
The purpose of this study is to evaluate the effect of perhexiline on exercise performance (efficacy) and safety in patients with hypertrophic cardiomyopathy and moderate-to-severe heart failure following dosing for 16 weeks.
- Trial name
- NCT02862600
- Testing
- Perhexiline, Use of bioanalytical assay to monitor plasma levels of perhexiline
- Where
- 11 sites in United States
- Volunteers
- 35 people
- Sponsor
- Heart Metabolics Limited
Aortic Stenosis
ACURATE IDE: Safety and Effectiveness Study of ACURATE Valve for Transcatheter Aortic Valve Replacement
To evaluate safety and effectiveness of the ACURATE Transfemoral Aortic Valve System for transcatheter aortic valve replacement (TAVR) in subjects with severe native aortic stenosis who are indicated for TAVR.
- Trial name
- NCT03735667
- Testing
- ACURATE neo2™ Transfemoral TAVR System, Medtronic CoreValve TAVR System, Edwards SAPIEN 3 TAVR System
- Where
- 75 sites in United States, Canada
- Volunteers
- 1,948 people
- Sponsor
- Boston Scientific Corporation
Aortic Valve Stenosis, Aortic Valve Failure
Portico Valve-in-Valve Retrospective Registry
The objective of this data-collection study is to retrospectively evaluate the safety and clinical performance of the Portico transthoracic aortic valve for Valve-in-Valve treatment of a failed aortic surgical bioprosthetic valve…
- Conditions
- Aortic Valve Stenosis, Aortic Valve Failure, Aortic Insufficiency, Aortic Stenosis
- Trial name
- NCT05002088
- Testing
- Transcatheter Aortic Valve Replacement
- Where
- 7 sites in Australia, Denmark and 2 more
- Volunteers
- 71 people
- Sponsor
- Abbott Medical Devices
Aortic Valve Stenosis
A Registry to Evaluate the Direct Flow Medical Transcatheter Aortic Valve System
The purpose of this postmarket Registry is to assess the standard of care and clinical outcomes of the Direct Flow Medical Transcatheter Aortic Valve System used in clinical routine according to the approved commercial…
- Trial name
- DISCOVER (NCT01845285)
- Testing
- Aortic Valve Replacement
- Where
- 2 sites in Germany, Italy
- Volunteers
- 1,000 people
- Sponsor
- Direct Flow Medical, Inc.
Aortic Stenosis, Valvular Heart Disease
ADVANCE Direct Aortic Study
This study is intended to collect data regarding the clinical utility, safety and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI) in patients with severe symptomatic aortic valve…
- Trial name
- NCT01676727
- Testing
- CoreValve aortic valve
- Where
- 9 sites in Czechia, France and 4 more
- Volunteers
- 100 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Aortic Valve Stenosis, Heart Valve Diseases
RHEIA (Randomized researcH in womEn All Comers With Aortic Stenosis)
Purpose of this prospective, randomized, controlled, multi-center study is to evaluate the safety and efficacy of Transcatheter Aortic Valve Implantation (TAVI) as compared to surgical aortic valve replacement (SAVR) in female…
- Trial name
- RHEIA (NCT04160130)
- Testing
- Transcatheter aortic valve replacement
- Where
- 48 sites in Austria, Belgium and 10 more
- Volunteers
- 432 people
- Sponsor
- Optimapharm
Aortic Stenosis
Self-Centering Guide Catheter Feasibility Study
An evaluation of the feasibility of using the Self-Centering Guide Catheter to deliver a guide wire across a stenotic native aortic valve into the left ventricle.
- Trial name
- NCT02639494
- Testing
- Self-Centering Guide Catheter
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Boston Scientific Corporation
Hypertrophic Obstructive Cardiomyopathy
First-in-Man Early Feasibility Study for Transcatheter HOCM Septal Ablation
Transcatheter Intra-septal RF ablation system (TIRA catheter with its supplemental devices) to treat hypertrophic obstructive cardiomyopathy.
- Trial name
- NCT04770142
- Testing
- TIRA catheter
- Where
- 9 sites in South Korea
- Volunteers
- 5 people
- Sponsor
- Tau-MEDICAL Co., Ltd.
Severe Symptomatic Calcified Native Aortic Valve Stenosis
Cerebral Protection in Transcatheter Aortic Valve Replacement
The Sentinel System will be a safe and effective method for capturing and removing embolic material (thrombus/debris) during transcatheter aortic valve replacement in order to reduce the ischemic burden in the cerebral anterior…
- Trial name
- NCT02214277
- Testing
- Cerebral Protection System-The SENTINEL System with TAVR, TAVR
- Where
- 15 sites in United States, Germany
- Volunteers
- 363 people
- Sponsor
- Claret Medical
Healthy Participants
A Study to Evaluate the Effects of Mavacamten in Healthy Participants
The purpose of the study is to evaluate the effect between two different single doses of mavamten in healthy participants.
- Trial name
- NCT05719805
- Testing
- Mavacamten
- Where
- 2 sites in United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Severe Aortic Stenosis
Safety and Efficacy Continued Access Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in Very High Risk Subjects and High Risk Subjects Who Need Aortic Valve Replacement
The purpose of the study is to evaluate the safety and efficacy of the Medtronic CoreValve® System in the treatment of symptomatic severe aortic stenosis in subjects who have a predicted very high risk and high risk for aortic…
- Trial name
- NCT01531374
- Testing
- Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
- Where
- 45 sites in United States
- Volunteers
- 2,777 people
- Sponsor
- Medtronic Cardiovascular
Severe Aortic Stenosis, Transcatheter Aortic Valve Replacemen
Alwide Plus China Post-market Clinical Investigation
This is a prospective, single-arm, multi-center, post-market registry study conducted in China. The purpose is to evaluate the safety and effectiveness of the AlwideTM Plus balloon catheter for pre-dilatation of the aortic valve…
- Trial name
- NCT07304427
- Where
- 4 sites in China
- Volunteers
- 75 people
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Moderate Aortic Stenosis
Comparison of Myval THV Series With Guideline-Directed Medical Therapy in Participants With Moderate Aortic Stenosis
The primary objective of this trial is to evaluate the safety and effectiveness of Meril's Myval THV series in comparison to Guideline-Directed Medical Therapy in participants with moderate aortic stenosis.
- Trial name
- NCT07532317
- Testing
- Transcatheter aortic valve Implantation
- Volunteers
- 778 people
- Sponsor
- Meril Life Sciences Pvt. Ltd.
Aortic Diseases
INFLATE Study: Investigation of the Safety and Performance of a Novel PTV Balloon in Patients Undergoing TAVI for Severe Aortic Stenosis
This clinical investigation is being done to evaluate the safety and effectiveness of a new device, a PTV Balloon, that will be used to open up an area in the heart (the valve) before and potentially after placing a new valve in…
- Trial name
- NCT06816485
- Testing
- PTV (Percutaneous Transcatheter Valvuloplasty) Balloon
- Where
- 9 sites in Spain
- Volunteers
- 93 people
- Sponsor
- Biosensors Europe SA